Webinar Information


Best Practices for Proper Deviation Management


Webinar Title
Best Practices for Proper Deviation Management
Event Type
Webinar
Webinar Date
15-11-2017
Last Date for Applying
15-11-2017
Location
Philadelphia, Pennsylvania, United States

Publish / Maintain / Marketing / Hosted By
Organization Name / Organize By
COMPLYARENA
Organizing/Related Departments
COMPLYARENA
Organization Type
Training/Development
Webinar Category
Both (Technical & Non Technical)
Webinar Level
All (State/Province/Region, National & International)
Related Industries

Biotechnology

Medical/Healthcare/Hospital

Location
Philadelphia, Pennsylvania, United States
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Course Description:

One of the most common FDA 483 and Warning Letter citations continues to be inadequate investigations. The FDA uses the investigation reports and investigation trends to identify potential quality problems in all areas of the company. Ultimately, inadequate investigations can lead to 483 citations, Warning Letters, release of sub-standard product, or product recall. Furthermore, costly and time-consuming system remediation may be required. Having a procedure on Deviation Investigations is not enough. It is the content and conclusions of the investigations themselves that truly count. Doing a proper root cause analysis, gathering evidence and ensuring a sustainable corrective action is key to a proper deviation investigation. This webinar will help attendees understand the fundamental investigation steps and skill sets. Key focus will be placed on identification and initial reporting of deviations, fact/evidence gathering, and arriving at the correct root cause and CAPA. The importance of investigation planning, critical thinking skills and effective preventative action plans will also be discussed.

Why should you attend?

This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA. This webinar will focus on how to avoid the pitfalls that may occur during FDA inspections and help eliminate 483 observations. Learn how to identify and avoid potential pitfalls during deviation investigations

Areas covered:

  • Review of FDA and Regulatory Requirements for Investigations
  • What is the definition of a Deviation?
  • Types of Deviations/Identification of Deviations
  • Conducting the Investigation
  • Interviews – dos and don’ts
  • Source Documents/Evidence
  • Determining Root Cause and Effective/Sustainable CAPA to avoid 483 observations

Others Details

For more details & updates please visit website

Registration Fees
Available
Registration Fees Details
https://www.complyarena.com/webinardetails/Best-Practices-for-Investigating-Deviations
Registration Ways
Email
Phone
Website
Post Box
Address/Venue
ONLINE 
Contact
KARTHIK

karthik.r@complyarena.com

     888 222 5917
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